N/A
N=20
Reassure Spot Respiration Rate Accuracy Compared to SOMNOScreen
Accuracy of Measurement of Respiration Rate
Bottom Line
View on ClinicalTrials.gov: NCT02740504 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Respiration Rate Accuracy — 0.4 breaths per minute
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ResMed
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Respiration Rate Accuracy |
0.4 | — |
Summary
A trial conducted within the company with a new non-contact respiration rate (RR) sensor. The device was compared for accuracy in RR measurement with a cleared device, the SOMNOScreen Easy, which uses chest effort bands.
The RR was measured over a short duration on subjects sitting upright in a chair, with the non-contact sensor at various distances from the subject. A total of 20 subjects were tested, from both genders, selected to represent a wide range of age and body mass index
Eligibility Criteria
Inclusion Criteria
- Greater or equal to 18 years old and less than or equal to 75 years old
- BMI within the range of greater or equal to 18 and less than or equal to 45
Data sourced from ClinicalTrials.gov (NCT02740504). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.